Omeros Inks Agreement With FDA For OMS721 Phase III Trial

Omeros Corporation (NASDAQ:OMER) announced that it has entered into an agreement with the FDA on its protocol to start a phase III study to evaluate its lead pipeline candidate, OMS721, for treatment of patients with IgA nephropathy (IgAN). Enrollment of patients for the study is expected to start early next month.

Notably, OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2).

Shares of Omeros have outperformed the industry in a year. The stock has soared 88.2% compared with the industry’s rally of 26.7%.

The single arm phase III study will be conducted on biopsy-confirmed IgAN patients aged minimum 18 years. In the trial, patients will be administered with intravenous doses of OMS721 through 12 weeks. The primary endpoint of the study will be reduction of proteinuria after the dosing starts. To further evaluate the safety and efficacy of the candidate, the initial sample size is estimated at 140 patients in either of the treatments including the placebo arm.

The company said that based on the degree of effect on proteinuria, either full or an accelerated approval for the candidate is possible in the United States.

We remind investors that in June last year, the FDA had granted a breakthrough therapy designation to OMS721. It is important to note that this designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. It has also been granted an orphan drug designation by the FDA for the given indication. Additionally, the orphan drug status for the candidate in the EU is pending.

Meanwhile, OMS721 is also being evaluated in a phase III clinical program for atypical hemolytic uremic syndrome (aHUS) in both the United States and the EU. The candidate has been granted both fast track and orphan drug designations for aHUS by the FDA.

Meanwhile, the company has recently initiated another phase III study for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA).

Per the company, approximately 120,000 to 180,000 patients in the United States suffer from IgA nephropathy. Absence of an approved treatment for IgA nephropathy reflects a significant unmet need for the same. Approximately 40% of IgA nephropathy patients develop end-stage renal disease.

The successful development and a subsequent approval of the candidate will significantly boost the company’s growth prospects.

We note that Alexion Pharmaceuticals, Inc.'s (NASDAQ:ALXN) Soliris is also approved for aHUS.

Omeros’ portfolio comprises a single approved drug, Omidria. The drug was launched in the United States in the second quarter of 2015 for its use during cataract surgery or intraocular lens or IOL replacement.

Zacks Rank & Key Picks

Omeros carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) and AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sucampo’s earnings per share estimates have moved north from $1.15 to $1.19 for the current year in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. Share price of the company has surged 28.6% year to date.

AcelRx stock has seen the Zacks Consensus Estimate loss per share being narrowed from $1.08 to $1.07 for 2017 and from $1.02 to 99 cents over the last 30 days.

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